MAGNESIUM STEARATE 99% USP, PH EUR EXTRA PURE
Pharmaceutical Grade
DESCRIPTION
Magnesium stearate is often used as an anti-adherent in the manufacture of medical tablets, capsules and powders. In this regard, the substance is also useful because it has lubricating properties, preventing ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets; magnesium stearate is the most commonly used lubricant for tablets. However, it might cause lower wettability and slower disintegration of the tablets and slower and even lower dissolution of the drug.
Magnesium stearate can also be used efficiently in dry coating processes.
Magnesium stearate is also used to bind sugar in hard candies like mints, and is a common ingredient in baby formulas.
Specification
Items | Unit | Specification | Results |
Appearance | Visual | Conform | Conform |
Loss on Drying at 105°C | % | 0.000 – 6.000 | 1.970 |
Magnesium Content | % Mg | 4.000 – 5.000 | 4.590 |
Magnesium Oxide | % MgO | 6.700 – 8.300 | 7.620 |
Identification A (Phar. Eur.) | °C | 53.000 – 90.000 | 55.000 |
Identification B (Phar.Eur.) | mgKOH/g | 195.000 – 210.000 | 199.000 |
Free fatty acid | % oleic | 0.000 – 3.000 | 1.100 |
Acidity or Alkalinity | Test | Conform | Conform |
Identification D (Eur)&A(US) | – | Conform | Conform |
Specific surface area | m2/g | 1.500 – 3.500 | 2.380 |
Nickel | ppm Ni | 5 max | Conform |
Mercury | ppm Hg | 1 max | Conform |
Lead | ppm Pb | 2 max | Conform |
Arsenic Content | ppm As | 3 max | Conform |
Cadmium | ppm Cd | 1 max | Conform |
Sulphates | % SO4 | 1 max | Conform |
Chloride | % Cl | 0.1 max | Conform |
Identification C(Eur) & B (US) | – | Conform | Conform |
Fatty acid content (C16+C18) | % | 90.000 – 100.000 | 98.800 |
Fatty acid (C18) content | % | 40,000 – 100.000 | 40.800 |
Unsaponifiables | % | 0.000 – 2.000 | 0.400 |
Microbiological Test | CFU/g | Conform | Conform |
Total aerobic microbial count | CFU/g | 1000 max | Conform |
Salmonella species | CFU/ 10g | Absence | Conform |
Escherichia Coli | CFU/g | Absence | Conform |
Total combined moulds & yeast | CFU/g | 100 max | Conform |
Organic impurities volatile | – | Conform | conform |